{"description":"The investigator or investigator's team will report all protocol defined SAEs and ECIs to the Sponsor (MedSIR) no later than 24 hours of any site study team staff becoming aware of the event. The full details of the SAE and/or ECI should be collected and fully documented using theSAE form. Follow-up information will be sent along with the SAE form, if available on the day the event is reported or as soon as possible.","eventGroups":[{"deathsNumAffected":16,"deathsNumAtRisk":18,"description":"Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle.\n\nRetifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":18,"seriousNumAffected":5,"seriousNumAtRisk":18,"title":"Interventional Arm"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Transaminases increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":8}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Xerosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Skin oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Decreased appetite"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Groin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Postoperative wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Superinfection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Skin wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Tumour ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Aspartate aminotransferase increased"}],"timeFrame":"From baseline until disease progression or treatment discontinuation, plus 28 days of follow-up after discontinuation (up to approximately 11.3 months)"}